BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 18295325 · Received December 8, 2023

    Report

    Report Number
    2214133-2023-00038
    Event Type
    Injury
    Date Received
    December 8, 2023
    Report Date
    November 17, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    4901730080156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A1, A2, A3, A4, A5: PATIENT IDENTIFIER, PATIENT¿S AGE, GENDER, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (BAND AID BRAND KKP JUMBO 3CT AP 4901730080156 4901730080156APA 4901730080156APA, LOT/CTRL # NI). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1CT USA 381371175338 8137117533USA 8137117533USA). LOT NUMBER WAS NOT AVAILABLE. UDI #: (B)(4), UPC # 4901730080156, D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. HEALTH EFFECT CLINICAL CODE: E2315 ALSO REFERS FOR CONSUMER ALLEGED THAT THICK BROWN THING SEEMED TO COME OUT OF A WOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CONSUMER REPORTED AN EVENT WITH BAND AID BRAND KPP JUMBO BANDAGE. CONSUMER REPORTED THAT ON (B)(6) 2023 THE BANDAGE WAS USED FOR A WOUND. CONSUMER REPORTED THAT A THICK BROWN THING SEEMED TO COME OUT OF THE WOUND AND IT WAS ALSO ON THE WOUND WHEN CONSUMER REMOVED THE STRIP. CONSUMER SOUGHT MEDICAL ATTENTION AND WAS TOLD THAT NO SUPPURATION WAS NOTED, AND AN UNKNOWN OINTMENT WAS PRESCRIBED. CONSUMER HAS NOT APPLIED THE OINTMENT AS OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824113 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 4901730080156 4901730080156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention